Responsibilities
- Develop, optimize, and execute analytical methods intended for a variety of purposes, including release and stability testing, product characterization, high-throughput analysis, and perform assays for characterization of complex raw materials.
- Review, interpret, and present data within the analytical team and cross-functionally.
- Provide technical oversight for troubleshooting and phase-appropriate qualification and validation of analytical assays for the analysis of gRNA, mRNA, and LNP.
- Work in partnership with internal and/or external QC to coordinate analytical method transfer within the organization or at Contract Manufacturing Organizations (CMOs)/Contract Testing Laboratories (CTLs).
- Author, review, and revise technical source documents to support phase-appropriate comparability.
- Serve as the CMC representative on cross-functional project teams.
- Provide technical oversight to guide analytical/QC investigations, as needed.
- Actively collaborate with internal and external process development and quality teams.
- Train and mentor junior team members.
Requirements
- B.S. in Analytical Chemistry, Biochemistry, Biophysics, or related field with 3-4 years of biotech industry experience or M.S. degree with 1-2 year of biotech industry experience.
- Analytical chemistry laboratory skills.
- Experience with the following: HPLC/UPLC and CE.
- Previous experience developing methods for mRNA (gRNA and LNP are a plus).
- Strong leadership, initiative, and teambuilding skills.
- Ability to perform multiple tasks simultaneously.
- Proactive and positive mindset.
Nice to Have
- Ph.D. in Analytical Chemistry, Biochemistry, Biophysics, or related field with 2-4 years of biotech industry experience or M.S. degree with 3-7 years of biotech industry experience or B.S. degree with 5+ years of biotech industry experience.
- Experience with HPLC/UPLC, MS, UV/Vis, and FTIR.
- Strong understanding of advanced characterization technologies and data interpretations such as cryo-TEM, NMR, DLS, AUC, etc.
- Authorization to work in the United States indefinitely without restriction or sponsorship.
Benefits
- Comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
